Technical Source is looking for a Systems Engineer to support our Medical Device client in the Raleigh, NC area! For this role, we're looking for those that have experience with medical devices such as X-Ray machines, MRI Machines, CAT Scans, surgical robotics, or other medical imaging devices. Ideally the candidate we're looking for will have experience within both the hardware and software side development of these devices, but will be focused a bit more on the software side. Even more specifically, this role will be really focused on how these systems and subsystems communicate to each other

Essential Functions/Responsibilities

• Define system and subsystem-level design specifications based on established requirements.
• Develop system and subsystem components to meet design and functional goals
• Work with Systems Test Engineer to create test methods and protocols for validating system and subsystem performance
• Collaborate with the Hardware Team to prototype and evaluate new and updated circuit boards in accordance with medical device design control standards
• Work with the Hardware Team to prototype and validate firmware and hardware-specific software for both new and existing X-ray systems and components
• Partner with the Software and Hardware Teams to manage the Windows imaging lifecycle, including creation, maintenance, and deployment of system images

Required experience

• Experience with medical devices systems and hardware design under design control. (Medical imaging devices are a big plus)
• Working knowledge of IEC 60601 standard. ESD/EMI/EMC testing knowledge
• Design control (ISO 13485)
• Risk management (ISO 14971)
• Usability of medical devices as it relates to safety (IEC 62366) is a plus